CompletedPhase 4ACTRN12620000339954

Comparing the effectiveness of testosterone-blocking medications in trans and gender diverse individuals

A randomised double-blind trial comparing the effectiveness of anti-androgen medications in trans and gender diverse individuals


Sponsor

Austin Health

Enrollment

64 participants

Start Date

Aug 31, 2020

Study Type

Interventional

Conditions

Summary

Transgender people desiring feminisation are often treated with estrogens and testosterone blocking medication. Spironolactone and cyproterone acetate are commonly used testosterone blocking medications, though it is unclear which is better at causing feminisation. This study will compare the effects of spironolactone and cyproterone acetate on breast growth, body composition and testosterone levels.


Eligibility

Sex: Both males and femalesMin Age: 16 YearssMax Age: 80 Yearss

Inclusion Criteria1

  • Transgender individuals newly commencing feminising therapy with anti-androgen medication

Exclusion Criteria3

  • Androgen deficiency at baseline
  • Planned orchidectomy within 6 months
  • Contraindication to treatment with estradiol, spironolactone or cyproterone (e.g. estrogen sensitive cancer, venous thromboembolic events, hyperkalaemia, severe depression)

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Interventions

Estradiol therapy titrated as per 'Çheung AS et al. Position statement on the hormonal management of adult transgender and gender diverse individuals. Med J Aust 2019; 211 (3): 127-133. doi: 10.5694/

Estradiol therapy titrated as per 'Çheung AS et al. Position statement on the hormonal management of adult transgender and gender diverse individuals. Med J Aust 2019; 211 (3): 127-133. doi: 10.5694/mja2.50259' Arm 1: Spironolactone 100mg daily (oral tablet) x 6 months ' Adherence monitored through unused product return


Locations(1)

Austin Health - Austin Hospital - Heidelberg

VIC, Australia

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ACTRN12620000339954